Application Nr Approved Date Route Status External Links
ANDA206962 2016-11-30 Intravenous RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Topotecan For Injection Is A Topoisomerase Inhibitor Indicated For: Metastatic Carcinoma Of The Ovary After Disease Progression On Or After Initial Or Subsequent Chemotherapy. (1.1) Small Cell Lung Cancer Platinum-Sensitive Disease In Patients Who Progressed After First-Line Chemotherapy. (1.2) Combination Therapy With Cisplatin For Stage Iv-B, Recurrent, Or Persistent Carcinoma Of The Cervix Which Is Not Amenable To Curative Treatment. (1.3) 1.1 Ovarian Cancer Topotecan For Injection, As A Single Agent, Is Indicated For The Treatment Of Patients With Metastatic Carcinoma Of The Ovary After Disease Progression On Or After Initial Or Subsequent Chemotherapy. 1.2 Small Cell Lung Cancer Topotecan For Injection, As A Single Agent, Is Indicated For The Treatment Of Patients With Small Cell Lung Cancer With Platinum-Sensitive Disease Who Progressed At Least 60 Days After Initiation Of First-Line Chemotherapy. 1.3 Cervical Cancer Topotecan For Injection In Combination With Cisplatin Is Indicated For The Treatment Of Patients With Stage Iv-B, Recurrent, Or Persistent Carcinoma Of The Cervix Not Amenable To Curative Treatment.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Topotecan Hydrochloride TOPOTECAN HYDROCHLORIDE ZINC1611274

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